Diagnostic performance of a urine-based ELISA assay for the screening of human schistosomiasis japonica: A comparative study

Mu, Yi; Weerakoon, Kosala; Olveda, Remigio M.; Ross, Allen G.; McManus, Donald P.; Cai, Pengfei

doi:10.3389/fmicb.2022.1051575

Cited by 4 publications

(3 citation statements)

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“…The human cohort had a moderate schistosomiasis japonica prevalence (26.2%) but a low intensity of infection based on the KK analysis on faecal samples (6 slides on two stool samples), according to the categorization by WHO. Detailed information of the study cohort can be found in previous studies ( 18 , 51 , 52 ).…”

Section: Resultsmentioning

confidence: 99%

Comparative assessment of the SjSAP4-incorporated gold immunochromatographic assay for the diagnosis of human schistosomiasis japonica

Mu,

Rivera,

McManus

et al. 2023

Front. Public Health

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BackgroundSchistosomiasis, a disease caused by parasites of the genus Schistosoma, remains a global public health threat. This study aimed to validate the diagnostic performance of a recently developed gold immunochromatographic assay (GICA) for the detection of S. japonicum infection in a rural endemic area of the Philippines.MethodsHuman clinical samples were collected from 412 subjects living in Laoang and Palapag municipalities, Northern Samar, the Philippines. The presence of Schistosoma-specific antibodies in serum samples was tested with the SjSAP4-incorporated GICA strips and the results were converted to fully quantitative data by introducing an R value. The performance of the established GICA was further compared with other diagnostic tools, including the Kato-Katz (KK) technique, point-of-care circulating cathodic antigen (POC-CCA), droplet digital (dd) PCR, and enzyme-linked immunosorbent assays (ELISAs).ResultsThe developed GICA strip was able to detect KK positive individuals with a sensitivity of 83.3% and absolute specificity. When calibrated with the highly sensitive faecal ddPCR assay, the immunochromatographic assay displayed an accuracy of 60.7%. Globally, the GICA assay showed a high concordance with the SjSAP4-ELISA assay. The schistosomiasis positivity rate determined by the GICA test was similar to those obtained with the SjSAP4-ELISA assay and the ddPCR assay performed on serum samples (SR_ddPCR), and was 2.3 times higher than obtained with the KK method.ConclusionThe study further confirms that the developed GICA is a valuable diagnostic tool for detecting light S. japonicum infections and implies that this point-of-care assay is a viable solution for surveying endemic areas of low-intensity schistosomiasis and identifying high-priority endemic areas for targeted interventions.

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Section: Resultsmentioning

confidence: 99%

Comparative assessment of the SjSAP4-incorporated gold immunochromatographic assay for the diagnosis of human schistosomiasis japonica

Mu,

Rivera,

McManus

et al. 2023

Front. Public Health

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“…The study recruited human subjects from 18 barangays moderately endemic (27% prevalence) for schistosomiasis japonica in the municipalities of Laoang and Palapag, Northern Samar, Philippines, in 2015 ( 3 , 18 , 39 , 42 ). Fecal and serum samples were collected from the participating subjects.…”

Section: Methodsmentioning

confidence: 99%

Development and assessment of a novel gold immunochromatographic assay for the diagnosis of schistosomiasis japonica

McManus

Gordon

et al. 2023

Front. Immunol.

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BackgroundThe neglected zoonosis, schistosomiasis japonica, remains a major public health problem in the Philippines. The current study aims to develop a novel gold immunochromatographic assay (GICA) and evaluate its performance in the detection of Schistosoma japonicum infection.MethodsA GICA strip incorporating a S. japonicum saposin protein, SjSAP4 was developed. For each GICA strip test, diluted serum sample (50 µl) was loaded and strips were scanned after 10 min to convert the results into images. ImageJ was used to calculate an R value, which was defined as the signal intensity of the test line divided by the signal intensity of the control line within the cassette. After determination of optimal serum dilution and diluent, the GICA assay was evaluated with sera collected from non-endemic controls (n = 20) and individuals living in schistosomiasis-endemic areas of the Philippines (n = 60), including 40 Kato Katz (KK)-positive participants and 20 subjects confirmed as KK-negative and faecal droplet digital PCR assay (F_ddPCR)-negative at a dilution of 1:20. An ELISA assay evaluating IgG levels against SjSAP4 was also performed on the same panel of sera.ResultsPhosphate-buffered saline (PBS) and 0.9% NaCl were determined as optimal dilution buffer for the GICA assay. The strips tested with serial dilutions of a pooled serum sample from KK-positive individuals (n = 3) suggested that a relatively wide range of dilutions (from 1:10 to 1:320) can be applied for the test. Using the non-endemic donors as controls, the GICA strip showed a sensitivity of 95.0% and absolute specificity; while using the KK-negative and F_ddPCR-negative subjects as controls, the immunochromatographic assay had a sensitivity of 85.0% and a specificity of 80.0%. The SjSAP4-incorperated GICA displayed a high concordance with the SjSAP4-ELISA assay.ConclusionsThe developed GICA assay exhibited a similar diagnostic performance with that of the SjSAP4-ELISA assay, yet the former can be performed by local personnel with minimal training with no requirement for specialised equipment. The GICA assay established here represents a rapid, easy-to-use, accurate and field-friendly diagnostic tool for the on-site surveillance/screening of S. japonicum infection.

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“…Several immunologic tests, including the indirect hemagglutination assay (IHA), enzyme-linked immunosorbent assay (ELISA), and rapid diagnostic tests (RDTs), have proven to be cost-effective and have been extensively employed for infection control and transmission control purposes (Lv et al 2022). However, they may face challenges related to lower specificity when utilizing crude extracted antigens and the difficulty of distinguishing between past and present infections (Mu et al 2023b). Furthermore, the use of nucleic acid-based diagnostic methods has shown higher performance in detecting various schistosome species, especially in low-level infections.…”

Section: Introductionmentioning

confidence: 99%

Recent Advances in the Diagnosis of Schistosomiasis

2023

IJAB

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Schistosomiasis is considered a neglected tropical disease instigated by flatworms of the genus Schistosoma, remnants a major problem in several parts of the world. A timely and accurate diagnosis is indispensable for disease management and control. Significant advances in the identification of schistosomiasis have been made in current years, improving our ability to detect and characterize infections. This chapter focuses on recent advances in schistosomiasis diagnosis, with an emphasis on new methods and approaches. Molecular diagnostic techniques, such as polymerase chain reaction (PCR), and loop-mediated isothermal amplification (LAMP), have exhibited the ability to improve schistosomiasis findings, sensitivity, and specificity. These techniques identify Schistosoma DNA in biological specimens such as blood, urine, and stool, allowing for early detection and monitoring of infections. Furthermore, the development of multiplex PCR assays allows for the finding of multiple Schistosoma species at the same time, which aids in species-specific diagnosis and epidemiological studies. In addition to molecular approaches, serological test-based antibody detection has advanced significantly. When compared to traditional methods, novel serological assays utilizing recombinant antigens and antigen-detection methods have demonstrated improved diagnostic accuracy, offering increased sensitivity and specificity. These tests not only detect current infections but also provide information about previous exposure to Schistosoma parasites. These non-invasive methods enable assisting in treatment decisions and assessing treatment efficacy. Finally, recent advances in schistosomiasis diagnosis have greatly expanded our diagnostic capabilities, allowing for more accurate and efficient infection detection. Molecular diagnostics, serological assays, and imaging modalities have all contributed to a better understanding of the disease and better patient care. Continuous research and innovation in diagnostic methods are required to improve global schistosomiasis control and elimination efforts.

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Diagnostic performance of a urine-based ELISA assay for the screening of human schistosomiasis japonica: A comparative study

Cited by 4 publications

References 53 publications

Comparative assessment of the SjSAP4-incorporated gold immunochromatographic assay for the diagnosis of human schistosomiasis japonica

Comparative assessment of the SjSAP4-incorporated gold immunochromatographic assay for the diagnosis of human schistosomiasis japonica

Development and assessment of a novel gold immunochromatographic assay for the diagnosis of schistosomiasis japonica

Recent Advances in the Diagnosis of Schistosomiasis

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